Immune Response to Influenza Vaccine is Maintained in MS Patients Treated With Rebif(R)
November 09 2005 - 2:01AM
PR Newswire (US)
Data Presented at XVIIIth World Congress of Neurology, Sydney,
Australia GENEVA, Switzerland, November 9 /PRNewswire-FirstCall/ --
Serono (virt-x: SEO and NYSE: SRA) Data presented today at the
XVIIIth World Congress of Neurology in Sydney, Australia, show that
treatment with Rebif(R) in patients with multiple sclerosis (MS)
does not alter the immune response to influenza vaccination. Immune
response to influenza vaccine was prospectively assessed in an
open-label study over a four-week period in a total of 163 patients
with MS. One group of MS patients (n=86) received Rebif(R)
(interferon beta-1a) 44 mcg subcutaneously three times weekly for
at least six months before administration of the flu vaccine and
continued their Rebif(R) treatment after the vaccination. The
control group of MS patients (n=77) did not receive interferon
treatment within six months prior to study entry and during the
study. Patients of both groups received a single dose of the same
influenza vaccine. The data from the two groups were similar on the
primary endpoint, defined by the proportion of patients achieving a
hemagglutination inhibition (HI) titer >40 four weeks after
vaccination, which indicates the ability of patients to mount a
positive vaccine response. More than 90% of the patients in both
groups (93% in the Rebif(R)-treated patients group and 91% in the
group of patients receiving no interferon treatment) were able to
mount an appropriate immune response. No new safety concerns
regarding the treatment of MS patients with Rebif(R) were
identified. The proportion of patients experiencing a
vaccine-related adverse event was similar for both the
Rebif(R)-treated group and the control group. "These results
demonstrate that treatment with Rebif(R) does not alter the immune
response to influenza vaccination, and that this vaccination can be
performed safely in MS patients who are treated with Rebif(R),"
said Dr. Paul Lammers, Chief Medical Officer of Serono, Inc. "This
news is important for patients treated with Rebif(R) as vaccination
may provide medical benefits to people with MS by preventing an
influenza virus infection, and also by possibly avoiding MS
exacerbations or worsening of neurologic symptoms due to concurrent
viral infection." The importance of MS patients avoiding viral
infections was previously outlined by the Immunization Panel of the
MS Council for Clinical Practice Guidelines. The meta-analysis
performed by the Panel demonstrated that MS subjects were at
increased risk of MS exacerbation during concurrent viral
infections. Rebif(R) is the only approved MS therapy proven in a
four-year clinical study in the following three key measures of
treatment effectiveness: reducing MRI lesion area and activity[1],
reducing relapses and delaying the progression of disability.
Rebif(R) is also supported by eight years of safety and efficacy
data. About Rebif(R) Rebif(R) (interferon beta-1a) is a
disease-modifying drug used to treat relapsing forms of multiple
sclerosis and is similar to the interferon beta protein produced by
the human body. Interferon helps modulate the body's immune system,
fight disease and reduce inflammation. Rebif(R), which was approved
in Europe in 1998 and in the US in 2002, is registered in more than
80 countries worldwide. In the United States, Rebif(R) is
co-marketed by Serono, Inc. and Pfizer Inc. Rebif(R) has been
proven to reduce MRI lesion activity and area[1], reduce the
frequency of relapses, and delay the progression of disability.
Rebif(R) is available in a 22 mcg and 44 mcg ready-to-use
pre-filled syringe and can be stored at room temperature for up to
30 days if a refrigerator is not available. Most commonly reported
side effects are injection site disorders, flu-like symptoms,
elevation of liver enzymes and blood cell abnormalities. Patients,
especially those with depression, seizure disorders, or liver
problems, should discuss treatment with Rebif(R) with their
doctors. The exact relationship of antibody titers to vaccine
efficacy was not studied and is not known in patients receiving
Rebif(R). About multiple sclerosis Multiple sclerosis is a chronic,
inflammatory condition of the nervous system and is the most
common, non-traumatic, neurological disease in young adults.
Multiple sclerosis may affect approximately two million people
worldwide. While symptoms can vary, the most common symptoms of
multiple sclerosis include blurred vision, numbness or tingling in
the limbs and problems with strength and coordination. The
relapsing forms of multiple sclerosis are the most common. About
influenza Influenza is caused by a virus that attacks mainly the
upper respiratory tract - the nose, throat and bronchi and rarely
also the lungs. The infection usually lasts for about a week. It is
characterized by sudden onset of high fever, myalgia, headache and
severe malaise, non-productive cough, sore throat, and rhinitis.
Most people recover within one to two weeks without requiring any
medical treatment. In the very young, the elderly and people
suffering from medical conditions such as lung diseases, diabetes,
cancer, kidney or heart problems, influenza poses a serious risk.
In these people, the infection may lead to severe complications of
underlying diseases, pneumonia and death. Some of the statements in
this press release are forward looking. Such statements are
inherently subject to known and unknown risks, uncertainties and
other factors that may cause actual results, performance or
achievements of Serono S.A. and affiliates to be materially
different from those expected or anticipated in the forward-looking
statements. Forward-looking statements are based on Serono's
current expectations and assumptions, which may be affected by a
number of factors, including those discussed in this press release
and more fully described in Serono's Annual Report on Form 20-F
filed with the U.S. Securities and Exchange Commission on March 16,
2005. These factors include any failure or delay in Serono's
ability to develop new products, any failure to receive anticipated
regulatory approvals, any problems in commercializing current
products as a result of competition or other factors, our ability
to obtain reimbursement coverage for our products, the outcome of
government investigations and litigation and government regulations
limiting our ability to sell our products. Serono has no
responsibility to update the forward-looking statements contained
in this press release to reflect events or circumstances occurring
after the date of this press release. About Serono Serono is a
global biotechnology leader. The Company has eight biotechnology
products, Rebif(R), Gonal-f(R), Luveris(R), Ovidrel(R
)/Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and
Raptiva(R). In addition to being the world leader in reproductive
health, Serono has strong market positions in neurology, metabolism
and growth and has recently entered the psoriasis area. The
Company's research programs are focused on growing these businesses
and on establishing new therapeutic areas, including oncology.
Currently, there are approximately 30 ongoing development projects.
In 2004, Serono achieved worldwide revenues of US$2,458.1 million,
and a net income of US$494.2 million, making it the third largest
biotech company in the world. Its products are sold in over 90
countries. Bearer shares of Serono S.A., the holding company, are
traded on the virt-x (SEO) and its American Depositary Shares are
traded on the New York Stock Exchange (SRA). [1] The exact
relationship between MRI findings and the clinical status of
patients is unknown. DATASOURCE: Serono International S.A. CONTACT:
For more information, please contact: Corporate Media Relations:
Tel: +41-22-739-36-00, Fax: +41-22-739-30-85,
http://www.serono.com/. Corporate Investor Relations: Tel:
+41-22-739-36-01, Fax: +41-22-739-30-22, Reuters: SEO.VX / SRA.N,
Bloomberg: SEO VX / SRA US, Media Relations, USA: Tel:
+1-781-681-2340, Fax: +1-781-681-2935. Investor Relations, USA,
Tel: +1-781-681-2552, Fax: +1-781-681-2912
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